New FDA-approved Alzheimer’s blood test coming to Mayo Clinic
New FDA-approved Alzheimer’s blood test coming to Mayo Clinic
The U.S. Food and Drug Administration has approved the marketing of a new tool to that can test a person’s blood to diagnose Alzheimer's disease. The blood test is a groundbreaking development to confirm the disease in patients who are already experiencing cognitive decline.
MINNEAPOLIS (FOX 9) - The U.S. Food and Drug Administration has approved the marketing of a new tool that can test a person’s blood to diagnose Alzheimer's disease.
The blood test is a groundbreaking development to confirm the disease in patients who are already experiencing cognitive decline.
A game-changing blood test
What we know:
The diagnostic tool, called Lumipulse, is manufactured by the worldwide medical research and development firm Fujirebio. The procedure, called the G pTau 217/β-Amyloid 1-42 Plasma Ratio in-vitro diagnostic (IVD) test, measures the presence of the amyloid and tau proteins in the brain that build the plaques leading to Alzheimer's disease.
Fujirebio will now start distributing the diagnostic tests by the end of June to 37 Alzheimer's clinics across the United States, including Mayo Clinic in Rochester, Minnesota.
"I was very excited to get the news that there was an FDA approved test," said Alicia Algeciras-Schimnich, Ph.D. of Mayo Clinic, who’s been offering a version of the blood test for the past year in their laboratory. "It's just increasing the access to patients, and now many more laboratories will be able to offer this test."
Dr. Algeciras-Schimnich says Mayo hopes it will have the capacity to offer 1,000 to 5,000 blood tests a month with this new diagnostic protocol.
What patients say:
Tim Sandry admits he’s never had the best memory, but when he approached turning 67, he and his wife Ellen started noticing changes.
"I wanted to find out what's going on here," recalled Sandry when he and his wife decided to see a neurologist.
The doctor put him through a series of cognitive tests and determined he had what’s called mild cognitive impairment, which is a noticeable slowing of memory function. It wasn’t long after his cognitive tests that a new diagnostic spinal tap was available to detect the presence of Alzheimer’s disease. But it was invasive and painful.
"In the morning they took the spinal fluid, and then I had to stay very still for the rest of the day. And then they sent me home, and I had an awful headache for the next three days," said Sandry of the hospital procedure.
This new test would have saved him the pain and provided reliable results.
"Oh, so much difference," said Sandry about the chance to have a diagnostic blood test. "I mean, this blood test is going to shake things up dramatically, I believe."
Getting a faster diagnosis
Why you should care:
The faster a person experiencing cognitive decline can get a positive diagnosis of Alzheimer’s, the faster they can start taking one of two recently FDA-approved drugs to slow the progression of the disease. Those drugs are Leqembi and Kisunla.
"It makes it much quicker for those people to start treatment and to start looking at what options there are, whether it's clinical trials or medication," said Jenna Fink of the Alzheimer's Association Minnesota-North Dakota chapter.
Sandry has been on a regimen of Leqembi since his own diagnosis, and he believes it has dramatically slowed the disease in his own brain. "The sooner you get diagnosed, the quicker you can get on those drugs and the less damage this will do to your brain And the longer you will be able to function, cognitively," he said.
How accurate is it?
Dig deeper:
The new blood test not only speeds up the diagnosis process, it also offers more accuracy.
"The clinical diagnosis of Alzheimer's disease is only about 70-75% accurate," said Mayo’s Alicia Algeciras-Schimnich of the standard practice of cognitive testing and PET scans of the brain. Adding the blood biomarker test increases the accuracy of an Alzheimer’s diagnosis to 90-95%.
"So really, it is a significant improvement in the diagnosis for patients, which now can have an earlier answer for their symptoms," said Algeciras-Schimnich.
Minnesotans living with Alzheimer’s
By the numbers:
As many as 101,900 Minnesotans over the age of 65 are living with Alzheimer's, according to the 2025 facts and figures report by the Alzheimer's Association. That adds up to 10.7% of Minnesota adults over 65.
Alzheimer's affects more than just patients. For every patient, there are caregivers, many of them family members. When those numbers are added up, the Alzheimer's Association estimates there are 166,000 caregivers in Minnesota.
Across the nation, 7.2 million Americans are living with Alzheimer’s, and 74% are over the age of 75.